Safety Extension Study Of Leuprolide Acetate (Lupron Depot) In The Treatment Of Central Precocious Puberty

• ClinicalTrials.gov Identifier: NCT00667446
• Recruitment Status: Completed
• First Posted: April 28, 2008
• Results First Posted: December 10, 2013
• Last Update Posted: January 9, 2014
• Sponsor: AbbVie (prior sponsor, Abbott)
• Information provided by (Responsible Party): AbbVie ( AbbVie (prior sponsor, Abbott) )

• Study Type: Interventional
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: Precocious; Leuprolide Acetate; Luteinizing Hormone (LH); Gonadotrophin-releasing Hormone Agonist (GnRHa); Tanner Staging; Depot Formulation; Suppression of LH; Central Precocious Puberty (CPP); Gonadotrophin-releasing Hormone (GnRH); Lupron; GnRH Analog; Pediatrics Central Precocious Puberty
• Intervention: Drug: Leuprolide Acetate 3 Month Depot
• Enrollment: 72

Participant Flow

Recruitment Details	Participants who successfully completed and showed maintenance of luteinizing hormone suppression through the 6-month treatment period of the lead-in study L-CP07-167 (NCT00635817) received the same treatment in this study that they were previously assigned in the lead-in study.
Pre-assignment Details	At the end of the Treatment Period, participants who completed the study or prematurely discontinued from the study could enter the Safety Follow-Up Period.

Arm/Group Title	Leuprolide Acetate 3M Depot 11.25 mg	Leuprolide Acetate 3M Depot 30 mg
Arm/Group Description	Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart during the Treatment Period. During the Safety Follow-Up Period participants were offered standard of care treatment as deemed appropriate by the investigator.	Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart during the Treatment Period. During the the Safety Follow-Up Period participants were offered standard of care treatment as deemed appropriate by the investigator.
Period Title: Treatment Period (36 Months)
Started	34	38
Completed	11	13
Not Completed	23	25
Reason Not Completed
Ready to enter puberty based on age	13	15
Other	2	2
Personal reasons	2	2
Withdrawal by Subject	0	4
Not Adequately Suppressed on Therapy	3	0
Lost to Follow-up	1	0
Protocol Violation	1	1
Therapeutic Failure	1	1
Period Title: Safety Follow-up Period (12 Weeks)
Started	28	26
Completed	28	25
Not Completed	0	1
Reason Not Completed
No Longer Needed Treatment	0	1

Baseline Characteristics

Arm/Group Title		Leuprolide Acetate 3M Depot 11.25 mg	Leuprolide Acetate 3M Depot 30 mg	Total
Arm/Group Description		Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.	Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.	Total of all reporting groups
Overall Number of Baseline Participants		34	38	72
Baseline Analysis Population Description		Participants who received at least 1 dose of study drug in this extension study.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	34 participants	38 participants	72 participants
		8.50 (1.71)	8.45 (1.52)	8.47 (1.60)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	34 participants	38 participants	72 participants
	Female	32 94.1%	33 86.8%	65 90.3%
	Male	2 5.9%	5 13.2%	7 9.7%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone
Description	Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH < 4 mIU/mL. Peak-stimulated LH refers to the maximum LH concentration measured 30 and 60 minutes after a gonadotropin-releasing hormone agonist (GnRHa) stimulation test. Participants who failed suppression at previous visit and prematurely discontinued were counted as having failed future visits also. Final visit is the participant's last visit closest to Month 36.
Time Frame	Day 1, Months 6, 12, 24, and 36

Outcome Measure Data

Analysis Population Description

Intention-to-treat, defined as patients who received at least 1 dose of study drug with at least 1 post-baseline measurement of any maintenance of suppression variable, & did not prematurely discontinue in the 1st 30 days due to inadequate suppression at Month 6 of the lead-in study. N= the number of patients with available data at each time point.

Arm/Group Title	Leuprolide Acetate 3M Depot 11.25 mg	Leuprolide Acetate 3M Depot 30 mg
Arm/Group Description:	Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.	Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
Overall Number of Participants Analyzed	33	38
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Day 1 [N= 32, 37]	96.9; (83.78 to 99.92)	100.0; (90.51 to 100.00)
Month 6 [N=32, 36]	93.8; (79.19 to 99.23)	100.0; (90.26 to 100.00)
Month 12 [N=31, 32]	90.3; (74.25 to 97.96)	96.9; (83.78 to 99.92)
Month 24 [N=16, 18]	87.5; (64.65 to 98.45)	100.0; (81.47 to 100.00)
Month 36 [N=9, 11]	77.8; (39.99 to 97.19)	100.0; (71.51 to 100.00)
Final Visit [N=33, 36]	93.9; (79.77 to 99.26)	100.0; (90.26 to 100.00)

2. Secondary Outcome

Title	Percentage of Female Participants With Suppression of Basal Estradiol (Assay 1)
Description	The percentage of female participants with suppression of basal estradiol to prepubertal levels, defined as estradiol < 20 pg/mL. The estradiol assay was changed in June of 2010, and the lower limit of quantitation (LLOQ) was increased from 1 pg/mL to 10 pg/mL. This outcome measure reports data for assays performed before this change occurred, with an LLOQ of 1 pg/mL. Final visit is the participant's last visit closest to Month 36.
Time Frame	Day 1, Months 3, 6, 9, 12, and 24

Outcome Measure Data

Analysis Population Description

Intention-to-treat female population. N = the number of participants with available data at each time point.

Arm/Group Title	Leuprolide Acetate 3M Depot 11.25 mg	Leuprolide Acetate 3M Depot 30 mg
Arm/Group Description:	Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.	Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
Overall Number of Participants Analyzed	31	33
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Day 1 [N=28, 30]	96.4; (81.65 to 99.91)	100.0; (88.43 to 100.00)
Month 3 [N=29, 33]	100.0; (88.06 to 100.00)	100.0; (89.42 to 100.00)
Month 6 [N=26, 25]	100.0; (86.77 to 100.00)	100.0; (86.28 to 100.00)
Month 9 [N=18, 18]	100.0; (81.47 to 100.00)	100.0; (81.47 to 100.00)
Month 12 [N=10, 12]	100.0; (69.15 to 100.00)	100.0; (73.54 to 100.00)
Month 24 [N=1, 0]	100.0; (2.50 to 100.00)	NA [1]; (NA to NA)
Final Visit [N=31, 33]	100.0; (88.78 to 100.00)	100.0; (89.42 to 100.00)

[1]

No participants with available data at this time point

3. Secondary Outcome

Title	Percentage of Female Participants With Suppression of Basal Estradiol (Assay 2)
Description	The percentage of female participants with suppression of basal estradiol to prepubertal levels, defined as estradiol < 20 pg/mL. The estradiol assay was changed in June of 2010, and the lower limit of quantitation (LLOQ) was increased from 1 pg/mL to 10 pg/mL. This outcome measure reports data for assays performed after this change occurred, with an LLOQ of 10 pg/mL. Final visit is the participant's last visit closest to Month 36.
Time Frame	Months 6, 9, 12, 24, 30, and 36

Outcome Measure Data

Analysis Population Description

Intention-to-treat female population. N = the number of participants with available data at each time point.

Arm/Group Title	Leuprolide Acetate 3M Depot 11.25 mg	Leuprolide Acetate 3M Depot 30 mg
Arm/Group Description:	Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.	Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
Overall Number of Participants Analyzed	31	33
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Month 6 [N=4, 6]	100.0; (39.76 to 100.00)	83.3; (35.88 to 99.58)
Month 9 [N=13, 10]	61.5; (31.58 to 86.14)	40.0; (12.16 to 73.76)
Month 12 [N=20, 15]	45.0; (23.06 to 68.47)	60.0; (32.29 to 83.66)
Month 24 [N=14, 15]	50.0; (23.04 to 76.96)	53.3; (26.59 to 78.73)
Month 30 [N=9, 15]	33.3; (7.49 to 70.07)	26.7; (7.79 to 55.10)
Month 36 [N=7, 11]	28.6; (3.67 to 70.96)	36.4; (10.93 to 69.21)
Final Visit [N=24, 26]	29.2; (12.62 to 51.09)	30.8; (14.33 to 51.79)

4. Secondary Outcome

Title	Percentage of Male Participants With Suppression of Basal Testosterone
Description	The percentage of male participants with suppression of basal testosterone to prepubertal levels, defined as testosterone < 30 ng/dL. Final visit is the participant's last visit closest to Month 36.
Time Frame	Day 1, Months 3, 6, 9, 12, 24, 30, and 36

Outcome Measure Data

Analysis Population Description

Intention-to-treat male population. N = the number of participants with available data at each time point.

Arm/Group Title	Leuprolide Acetate 3M Depot 11.25 mg	Leuprolide Acetate 3M Depot 30 mg
Arm/Group Description:	Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.	Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
Overall Number of Participants Analyzed	2	5
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Day 1 [N= 2, 5]	100.0; (15.81 to 100.00)	100.0; (47.82 to 100.00)
Month 3 [N=2, 5]	100.0; (15.81 to 100.00)	100.0; (47.82 to 100.00)
Month 6 [N=2, 5]	100.0; (15.81 to 100.00)	80.0; (28.36 to 99.49)
Month 9 [N=2, 5]	100.0; (15.81 to 100.00)	80.0; (28.36 to 99.49)
Month 12 [N=1, 5]	100.0; (2.50 to 100.00)	100.0; (47.82 to 100.00)
Month 24 [N=1, 3]	100.0; (2.50 to 100.00)	66.7; (9.43 to 99.16)
Month 30 [N=0, 1]	NA [1]; (NA to NA)	100.0; (2.50 to 100.00)
Month 36 [N=0, 1]	NA [1]; (NA to NA)	100.0; (2.50 to 100.00)
Final Visit [N=2, 5]	100.0; (15.81 to 100.00)	100.0; (47.82 to 100.00)

[1]

No participants with available data at this time point

5. Secondary Outcome

Title	Mean Peak-stimulated Luteinizing Hormone Concentration by Visit
Description	Peak-stimulated luteinizing hormone refers to the maximum luteinizing hormone concentration measured 30 and 60 minutes after a gonadotropin-releasing hormone agonist (GnRHa) stimulation test. Final visit is the participant's last visit closest to Month 36.
Time Frame	Baseline of the lead-in study L-CP07-167, Day 1, Months 6, 12, 24, and 36

Outcome Measure Data

Analysis Population Description

Intention-to-treat. N = the number of participants with available data at each time point.

Arm/Group Title	Leuprolide Acetate 3M Depot 11.25 mg	Leuprolide Acetate 3M Depot 30 mg
Arm/Group Description:	Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.	Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
Overall Number of Participants Analyzed	33	38
Mean (Standard Deviation); Unit of Measure: mIU/mL
Baseline [N=33, 38]	21.89 (38.46)	10.16 (12.66)
Day 1 [N=32, 37]	2.00 (1.03)	1.49 (0.86)
Month 6 [N=32, 36]	2.22 (1.16)	1.62 (0.82)
Month 12 [N=31, 32]	2.24 (1.20)	1.58 (1.02)
Month 24 [N=14, 18]	1.67 (0.97)	0.88 (0.58)
Month 36 [N=7, 11]	1.51 (0.85)	0.91 (0.49)
Final Visit [N=33, 36]	1.81 (1.13)	1.15 (0.74)

6. Secondary Outcome

Title	Percentage of Female Participants With Suppression of the Physical Signs of Puberty (Breast Development)
Description	The percentage of female participants with suppression of breast development. Breast development was rated from Stage 1 (early development) through Stage 5 (full development) according to a modified Tanner Staging pictogram. Suppression of breast development is defined as regression or no progression of breast development from Baseline (of the lead-in study L-CP07-167) according to pubertal staging. Girls entering the study with fully developed breasts (Stage 5) were excluded from this analysis. Final visit is the participant's last visit closest to Month 36.
Time Frame	Baseline (of the lead-in study L-CP07-167), Day 1, Months 3, 6, 9, 12, 18, 24, 30, and 36

Outcome Measure Data

Analysis Population Description

Intention-to-treat female population, excluding participants who entered the study at Stage 5. N = the number of participants with available data at each time point.

Arm/Group Title	Leuprolide Acetate 3M Depot 11.25 mg	Leuprolide Acetate 3M Depot 30 mg
Arm/Group Description:	Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.	Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
Overall Number of Participants Analyzed	31	31
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Day 1 [N= 31, 31]	90.3; (74.2 to 98.0)	83.9; (66.3 to 94.5)
Month 3 [N=29, 31]	86.2; (68.3 to 96.1)	87.1; (70.2 to 96.4)
Month 6 [N=31, 30]	90.3; (74.2 to 98.0)	80.0; (61.4 to 92.3)
Month 9 [N=31, 28]	87.1; (70.2 to 96.4)	75.0; (55.1 to 89.3)
Month 12 [N=28, 26]	85.7; (67.3 to 96.0)	80.8; (60.6 to 93.4)
Month 18 [N=17, 20]	82.4; (56.6 to 96.2)	75.0; (50.9 to 91.3)
Month 24 [N=14, 16]	78.6; (49.2 to 95.3)	75.0; (47.6 to 92.7)
Month 30 [N=10, 16]	90.0; (55.5 to 99.7)	68.8; (41.3 to 89.0)
Month 36 [N=8, 12]	87.5; (47.3 to 99.7)	66.7; (34.9 to 90.1)
Final Visit [N=31, 31]	83.9; (66.3 to 94.5)	71.0; (52.0 to 85.8)

7. Secondary Outcome

Title	Percentage of Male Participants With Suppression of the Physical Signs of Puberty (Testicular Volume and Genital Development)
Description	The percentage of male participants with suppression of testicular volume and genital staging. Testicular volume was calculated from the length, width and height of each testicle measured by ultrasound. External genital development (testes and penis) was rated from Stage 1 (early development) through Stage 5 (full development) according to a modified Tanner Staging pictogram. Suppression is defined as regression or no progression in both testicular volume and genital staging from Baseline (of the lead-in study L-CP07-167) according to pubertal staging. Boys entering the study with fully developed genitals (Stage 5) were excluded from this analysis. Final visit is the participant's last visit closest to Month 36.
Time Frame	Baseline (of the lead-in study L-CP07-167), Day 1, Months 3, 6, 9, 12, 18, 24, 30, and 36

Outcome Measure Data

Analysis Population Description

Intention-to-treat male population, excluding participants who entered the study at Stage 5. N = the number of participants with available data at each time point.

Arm/Group Title	Leuprolide Acetate 3M Depot 11.25 mg	Leuprolide Acetate 3M Depot 30 mg
Arm/Group Description:	Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.	Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
Overall Number of Participants Analyzed	2	5
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Day 1 [N= 2, 5]	50.0; (1.3 to 98.7)	40.0; (5.3 to 85.3)
Month 3 [N=2, 5]	50.0; (1.3 to 98.7)	60.0; (14.7 to 94.7)
Month 6 [N=2, 5]	50.0; (1.3 to 98.7)	60.0; (14.7 to 94.7)
Month 9 [N=2, 5]	50.0; (1.3 to 98.7)	40.0; (5.3 to 85.3)
Month 12 [N=1, 5]	100.0; (2.5 to 100.0)	60.0; (14.7 to 94.7)
Month 18 [N=1, 3]	100.0; (2.5 to 100.0)	100.0; (29.2 to 100.0)
Month 24 [N=1, 3]	100.0; (2.5 to 100.0)	33.3; (0.8 to 90.6)
Month 30 [N=1, 1]	100.0; (2.5 to 100.0)	100.0; (2.5 to 100.0)
Month 36 [N=0, 1]	NA [1]; (NA to NA)	100.0; (2.5 to 100.0)
Final Visit [N=2, 5]	50.0; (1.3 to 98.7)	20.0; (0.5 to 71.6)

[1]

No participants with available data at this time point

8. Secondary Outcome

Title	Change From Baseline in Growth Rate
Description	Baseline growth rate was the growth rate in the one year prior to Day 1 of the lead-in study L-CP07-167. Growth rates were calculated as the ratio of the change in height to the change in chronological age with an approximate 6-month interval for Day 1, Months 6, 12, 18, 24, 30, 36 and the Final Treatment Visit.
Time Frame	Baseline (the 1 year prior to the start of treatment in the lead-in study), and Day 1, Months 6, 12, 18, 24, 30, and 36

Outcome Measure Data

Analysis Population Description

Intention-to-treat with available growth rate data. N = participants with available data at each time point.

Arm/Group Title	Leuprolide Acetate 3M Depot 11.25 mg	Leuprolide Acetate 3M Depot 30 mg
Arm/Group Description:	Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.	Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
Overall Number of Participants Analyzed	32	38
Mean (Standard Deviation); Unit of Measure: cm/year
Baseline [N=32, 38]	7.2 (3.96)	7.53 (2.81)
Change from Baseline at Day 1 [N=32, 38]	-1.67 (3.90)	-1.65 (3.43)
Change from Baseline at Month 6 [N=32, 37]	-1.66 (3.78)	-2.04 (2.95)
Change from Baseline at Month 12 [N=28, 32]	-1.99 (3.90)	-2.28 (2.88)
Change from Baseline at Month 18 [N=18, 23]	-2.21 (4.29)	-2.06 (2.40)
Change from Baseline at Month 24 [N=15, 19]	-2.36 (4.85)	-1.59 (2.20)
Change from Baseline at Month 30 [N=11, 17]	-1.86 (5.45)	-2.13 (2.33)
Change from Baseline at Month 36 [N=8, 13]	-2.64 (5.93)	-2.19 (2.41)
Change from Baseline at Final Visit [N=32, 38]	-2.27 (3.78)	-2.64 (2.65)

9. Secondary Outcome

Title	Ratio of Change From Baseline in Bone Age/Change From Baseline in Chronological Age
Description	Bone age was determined by left hand/wrist bone age radiographs that were evaluated using the Fels Method by a central reader. The ratio of change from Baseline in bone age (BA)/change from Baseline in chronological age (CA) was calculated using the following formula: (BA at Post-baseline Treatment Visit - BA at Baseline) / (CA at Post-baseline Treatment Visit - CA at Baseline).
Time Frame	Baseline (of the lead-in study L-CP07-167), and Day 1, Months 12, 24, and 36

Outcome Measure Data

Analysis Population Description

Intention-to-treat with available bone age data. N = participants with available data at each time point.

Arm/Group Title	Leuprolide Acetate 3M Depot 11.25 mg	Leuprolide Acetate 3M Depot 30 mg
Arm/Group Description:	Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.	Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
Overall Number of Participants Analyzed	33	37
Mean (Standard Deviation); Unit of Measure: ratio
Day 1 [N=32, 37]	0.51 (0.56)	1.02 (1.27)
Month 12 [N=32, 32]	0.52 (0.33)	0.62 (0.37)
Month 24 [N=14, 17]	0.53 (0.30)	0.72 (0.34)
Month 36 [N=5, 11]	0.43 (0.15)	0.64 (0.30)
Final Visit [N=33, 32]	0.48 (0.28)	0.56 (0.30)

Adverse Events

Time Frame	37 months
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Leuprolide Acetate 3M Depot 11.25 mg	Leuprolide Acetate 3M Depot 30 mg
Arm/Group Description	Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.	Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
All-Cause Mortality
	Leuprolide Acetate 3M Depot 11.25 mg	Leuprolide Acetate 3M Depot 30 mg
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	Leuprolide Acetate 3M Depot 11.25 mg	Leuprolide Acetate 3M Depot 30 mg
	Affected / at Risk (%)	Affected / at Risk (%)
Total	1/34 (2.94%)	0/38 (0.00%)
Nervous system disorders
INTRACRANIAL PRESSURE INCREASED † 1	1/34 (2.94%)	0/38 (0.00%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA Version 15.1
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Leuprolide Acetate 3M Depot 11.25 mg	Leuprolide Acetate 3M Depot 30 mg
	Affected / at Risk (%)	Affected / at Risk (%)
Total	31/34 (91.18%)	31/38 (81.58%)
Ear and labyrinth disorders
EAR PAIN † 1	1/34 (2.94%)	2/38 (5.26%)
Eye disorders
MYOPIA † 1	0/34 (0.00%)	2/38 (5.26%)
Gastrointestinal disorders
ABDOMINAL PAIN † 1	2/34 (5.88%)	3/38 (7.89%)
ABDOMINAL PAIN UPPER † 1	2/34 (5.88%)	3/38 (7.89%)
CONSTIPATION † 1	2/34 (5.88%)	1/38 (2.63%)
DIARRHOEA † 1	3/34 (8.82%)	2/38 (5.26%)
NAUSEA † 1	2/34 (5.88%)	1/38 (2.63%)
VOMITING † 1	0/34 (0.00%)	4/38 (10.53%)
General disorders
INJECTION SITE PAIN † 1	10/34 (29.41%)	9/38 (23.68%)
PYREXIA † 1	6/34 (17.65%)	5/38 (13.16%)
Immune system disorders
SEASONAL ALLERGY † 1	2/34 (5.88%)	1/38 (2.63%)
Infections and infestations
BODY TINEA † 1	3/34 (8.82%)	0/38 (0.00%)
BRONCHITIS † 1	3/34 (8.82%)	0/38 (0.00%)
EAR INFECTION † 1	3/34 (8.82%)	1/38 (2.63%)
GASTROENTERITIS † 1	4/34 (11.76%)	4/38 (10.53%)
INFLUENZA † 1	3/34 (8.82%)	0/38 (0.00%)
NASOPHARYNGITIS † 1	3/34 (8.82%)	1/38 (2.63%)
PHARYNGITIS † 1	2/34 (5.88%)	1/38 (2.63%)
PHARYNGITIS STREPTOCOCCAL † 1	5/34 (14.71%)	4/38 (10.53%)
SINUSITIS † 1	2/34 (5.88%)	2/38 (5.26%)
UPPER RESPIRATORY TRACT INFECTION † 1	9/34 (26.47%)	5/38 (13.16%)
Injury, poisoning and procedural complications
EXCORIATION † 1	0/34 (0.00%)	2/38 (5.26%)
LIGAMENT SPRAIN † 1	0/34 (0.00%)	2/38 (5.26%)
Investigations
WEIGHT INCREASED † 1	0/34 (0.00%)	3/38 (7.89%)
Musculoskeletal and connective tissue disorders
ARTHRALGIA † 1	4/34 (11.76%)	5/38 (13.16%)
PAIN IN EXTREMITY † 1	3/34 (8.82%)	3/38 (7.89%)
Nervous system disorders
HEADACHE † 1	5/34 (14.71%)	6/38 (15.79%)
Respiratory, thoracic and mediastinal disorders
COUGH † 1	4/34 (11.76%)	9/38 (23.68%)
NASAL CONGESTION † 1	3/34 (8.82%)	5/38 (13.16%)
RESPIRATORY DISORDER † 1	1/34 (2.94%)	2/38 (5.26%)
RHINORRHOEA † 1	3/34 (8.82%)	1/38 (2.63%)
Skin and subcutaneous tissue disorders
ACNE † 1	2/34 (5.88%)	2/38 (5.26%)
ECZEMA † 1	2/34 (5.88%)	1/38 (2.63%)
RASH † 1	3/34 (8.82%)	1/38 (2.63%)
RASH PAPULAR † 1	2/34 (5.88%)	0/38 (0.00%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA Version 15.1

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.

Results Point of Contact

• Name/Title: Global Medical Services
• Organization: AbbVie, (prior sponsor, Abbott)
• Phone: 800-633-9110

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lee PA, Klein K, Mauras N, Lev-Vaisler T, Bacher P. 36-month treatment experience of two doses of leuprolide acetate 3-month depot for children with central precocious puberty. J Clin Endocrinol Metab. 2014 Sep;99(9):3153-9. doi: 10.1210/jc.2013-4471. Epub 2014 Jun 13.

• Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
• ClinicalTrials.gov Identifier: NCT00667446
• Other Study ID Numbers: L-CP07-177
• First Submitted: April 24, 2008
• First Posted: April 28, 2008
• Results First Submitted: October 16, 2013
• Results First Posted: December 10, 2013
• Last Update Posted: January 9, 2014